The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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29876–29900 of 40325

  • HighFDA (Devices)·Z-1941-2016·2016-06-15

    Materialise Recalls Patient-Specific Knee Surgical Guide Set Due to Fit Error

    Materialise USA LLC is recalling a patient-specific knee surgical guide set because the femur guide does not match the patient, preventing proper use during surgery.

    Product
    Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1922-2016·2016-06-15

    Baxter Recalls Actifuse Bone Void Fillers Due to Endotoxin Concerns

    Baxter Healthcare is voluntarily recalling Actifuse ABX and MIS System bone void fillers because they may contain endotoxin levels above specification criteria.

    Product
    Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2016·2016-06-15

    GE Revolution CT Patient Table Recalled for Unintended Motion Risk

    GE Healthcare is recalling Revolution CT Patient Tables because the cradle can descend on its own, posing a crushing risk to large patients.

    Product
    GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2016·2016-06-15

    Philips Brilliance iCT CT System Software Defect Recall

    Philips Healthcare is recalling Brilliance iCT Computed Tomography X-Ray Systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1832-2016·2016-06-15

    Hospira Recalls 1,490 Plum 360 Infusion Pumps Due to Calibration Error

    Hospira is recalling 1,490 Plum 360 infusion pumps because a calibration error may cause false proximal occlusion alarms.

    Product
    The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1912-2016·2016-06-15

    DePuy Synthes Flexible Shaft Reamers Recalled for Cytotoxicity Failure

    Synthes (USA) Products LLC is recalling 244 DePuy Synthes 8.0 mm Flexible Shaft Reamers because they failed biological safety evaluations for cytotoxicity.

    Product
    DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2016·2016-06-15

    Zimmer Biomet Recalls Persona Trabecular Metal Tibial Plate Instruments

    Zimmer Biomet is recalling specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets due to incidents of radiolucent lines and loosening in implants.

    Product
    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1925-2016·2016-06-15

    Berchtold Recalls Surgical Table Cushions Due to Potential Staple Contamination

    Berchtold Corp. is recalling 227 HybriGel surgical table cushions because they may contain staples that could appear on patient x-rays.

    Product
    Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2016·2016-06-15

    Philips Healthcare Ingenuity Core128 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Ingenuity Core128 CT systems in the US due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1937-2016·2016-06-15

    Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities

    Becton Dickinson is recalling 811,200 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.

    Product
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2016·2016-06-15

    Sedecal Mobile X-ray System Recalled for Software Defect

    Sedecal USA is recalling 145 mobile x-ray systems in the US due to a software defect that may apply adult exposure parameters to newborns.

    Product
    Sedecal SA Mobile Diagnost w DR x-ray system
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1936-2016·2016-06-15

    Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Issues

    Becton Dickinson is recalling 176,000 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.

    Product
    Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2016·2016-06-15

    Philips Brilliance 64 CT System Software Defect Recall

    Philips Healthcare is recalling 423 Brilliance 64 CT systems in the US due to software defects causing incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1926-2016·2016-06-15

    Medtronic RestoreSensor Implantable Neurostimulators Recalled for Battery Depletion

    Medtronic is recalling RestoreSensor implantable neurostimulators because insufficient coupling during recharging can cause rapid battery depletion and loss of therapy.

    Product
    Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1833-2016·2016-06-15

    Hospira Recalls 2,567 Plum A+ Infusion Pumps Due to Calibration Error

    Hospira is recalling 2,567 Plum A+ infusion pumps because a calibration error caused false occlusion alarms. The devices were distributed in the U.S. and 13 foreign countries.

    Product
    The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1716-2016·2016-06-15

    Philips Healthcare Ingenuity Core CT System Software Defect Recall

    Philips Healthcare is recalling Ingenuity Core CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1715-2016·2016-06-15

    Philips Brilliance iCT SP CT System Recalled for Software Defects

    Philips Healthcare is recalling Brilliance iCT SP CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1914-2016·2016-06-15

    Ortho VITROS 5600 System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.

    Product
    VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2016·2016-06-15

    Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software timing anomaly that may cause the device to aspirate or dispense into unintended samples, potentially leading to erroneous or contaminated results.

    Product
    VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1939-2016·2016-06-15

    Stryker Recalls Maestro Air Motor Pneumatic Cranial Drill Units

    Stryker is recalling 189 Maestro Air Motor pneumatic cranial drill units because grease buildup may cause the orange grease to leak and contaminate surgical wounds.

    Product
    Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1717-2016·2016-06-15

    Philips Ingenuity CT System Recalled for Software Defects

    Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1943-2016·2016-06-15

    DePuy Synthes Recalls Norian Drillable Inject Due to Labeling Error

    DePuy Synthes is voluntarily recalling Norian Drillable Inject 5 CC-Sterile units because the internal rotary pouch may be labeled with the incorrect powder volume, though the actual contents are correct.

    Product
    Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2016·2016-06-15

    Ellipse ND: YAG Laser Applicator Recalled for Missing Calibration Instructions

    Ellipse A/S is recalling 14 Ellipse ND: YAG Laser applicators because they lack required instructions for calibration procedures and schedules.

    Product
    Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
    Category
    Medical Device
    Distribution
    Distributed nationwide